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    Home > Medical News > Latest Medical News > Pralsettinib completed the first administration of RET fusion non-small cell lung cancer in China

    Pralsettinib completed the first administration of RET fusion non-small cell lung cancer in China

    • Last Update: 2020-02-14
    • Source: Internet
    • Author: User
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    February 13, 2020 / Meitong news agency / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical" or "company", Hong Kong stock exchange code: 2616) announced that the phase I / II Registration test of pralsettinib, a product under development developed by the company's partner blueprintmedicines, has completed the first RET fusion non-small cell lung cancer (NSCLC) in China that has not received platinum chemotherapy before Patient administration This trial is part of the arrow study to evaluate the overall response rate (ORR), duration of response (DOR), pharmacokinetics, pharmacodynamics and safety of pralsettinib in RET fusion NSCLC without previous platinum chemotherapy In China, lung cancer ranks first in the incidence rate of malignancy [1] In the world, about 80% - 85% of all lung cancers are NSCLC [2], while the incidence of RET fusion in this kind of lung cancer is about 1-2% [3] At present, the standard treatment of RET fusion NSCLC without platinum chemotherapy in China includes dual drug chemotherapy with platinum, single drug immunosuppressant or combination of dual drug chemotherapy with platinum, but the effect is not ideal, and the patients suffer great physiological and psychological pain, and the quality of life is seriously reduced Previously, in December 2019, China's clinical research center has completed the listing of RET fusion NSCLC patient team after platinum containing chemotherapy Cornerstone pharmaceutical plans to submit the new drug listing application of pralsettinib for the treatment of this indication to the National Drug Administration (nmpa) in the second half of 2020 Pralsettinib is an oral (once a day), powerful and highly selective RET inhibitor for RET fusion and mutation (including resistant mutations) Cornerstone pharmaceutical has reached an exclusive cooperation agreement with blueprintmedicines, and obtained the exclusive development and commercialization authorization of three drugs including pralsettinib in Greater China Blueprintmedicines reserves the relevant rights of these three drugs in the rest of the world Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said: "at present, there is no selective RET inhibitor approved in the world It's nice to see that the recruitment of patients from the arrow study in China has been expanded to ret fusion NSCLC without platinum chemotherapy in the past, which will enable us to evaluate the potential clinical benefits of pralsettinib in a broader RET fusion NSCLC population 2020 is an important year for cornerstone pharmaceutical industry to move towards commercialization We will submit a number of new drug applications including pralsettinib to nmpa to respond to the unmet clinical needs of cancer patients in China " Dr Yang Jianxin, chief medical officer of cornerstone pharmaceutical, said: "according to the latest published main efficacy data of the arrow study, pralsettinib showed exciting antitumor activity and long-lasting efficacy in the NSCLC fused with RET that had not received platinum containing chemotherapy before and NSCLC treated with platinum containing chemotherapy, with good safety and tolerance We will continue to fully promote the progress of this research in China, and bring new treatment options for more patients with RET fusion NSCLC, medullary thyroid cancer and other solid tumors " In January 2020, blueprint Medicine released the latest major efficacy data of arrow study in RET fusion NSCLC This efficacy data report the data of patients who received pralsettinib treatment and whose efficacy can be evaluated The data are based on the recist1.1 standard and independent center imaging blind method All patients received the recommended dose of 400mg once a day Data as of November 18, 2019, the results showed that [4]: in 80 patients with RET fusion NSCLC who had previously received chemotherapy containing platinum, the orr confirmed by independent center assessment was 61% (95% CI: 50-72%), two cases need to be confirmed; in general, imaging tumor reduction was observed in 95% of the patients, 14% of them achieved complete remission of the target focus Dor has not been achieved (95% CI: 11.3 months, cannot be estimated) In 26 patients with initial RET fusion NSCLC, Orr was 73% (95% CI: 52-88%) after independent center evaluation (all remissions were confirmed), and 12% of them achieved complete remission Tumor shrinkage was observed in all of these patients The main safety data of the study is consistent with the previously published data Pralsettinib was well tolerated, and most of the AES in the treatment were grade 1 to 2 In the arrow study, of all patients who received the recommended 400 mg daily dose (n = 354), only 4% stopped treatment due to adverse events related to pralsettinib About pralsettinib, pralsettinib is a kind of drug in research, which is oral (once a day), highly effective and highly selective, targeting carcinogenic RET variation Blueprint medicines is in the process of clinical development of pralsettinib for the treatment of RET variant non-small cell lung cancer, medullary thyroid cancer and other solid tumors The US FDA has awarded pralsettinib breakthrough therapy for the treatment of patients with RET fusion non-small cell lung cancer undergoing platinum chemotherapy, and patients with RET mutant medullary thyroid cancer who need systematic treatment and have no alternative treatment Pralsettinib was designed by blueprint medicine's team based on its proprietary compound library In preclinical studies, pralsettinib always showed subnanomolar potency against the most common RET fusion, activation and resistance mutations The selectivity of pralsettinib to ret was 90 times higher than that of VEGFR2 In addition, the selectivity of pralsettinib to ret was significantly higher than that of the approved inhibitors By inhibiting primary and secondary mutations, pralsettinib is expected to overcome and prevent the occurrence of clinical drug resistance This treatment is expected to achieve long-term clinical remission in patients with different RET variants, and has good safety About cornerstone Pharmaceutical (HKEx: 2616), a biopharmaceutical company, focuses on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the keen medical needs of cancer patients in China and around the world Founded at the end of 2015, cornerstone pharmaceutical has assembled a world-class management team with rich experience in new drug research and development, clinical research and commercialization With tumor immunotherapy as the core, the company has established a rich product pipeline composed of 15 tumor candidate drugs At present, five late candidate drugs are in critical clinical trials With experienced management team, rich pipeline, business model focusing on clinical development and abundant funds, the vision of cornerstone pharmaceutical industry is to become a world-renowned leading biopharmaceutical company in China by bringing innovative cancer therapy to cancer patients around the world References: [1] Chen W, et al Cancer statistics in China, 2015 CA cancer J Clin 2016; 66 (2): 115-32 [2] primary lung cancer diagnosis and treatment specification (2018) [3] data previously presented October 29, 2017 at aacr-nci-eortc Conference [4] press release from blueprint medicines Available from: http://ir.blueprintmedicines.com/news-releases/news - release details / blueprint medicines announcements top line data pralsettinib and 37
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